Tirzepatide + Exercise for Obesity
(EXER-MED Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines whether combining exercise with the weight loss medication tirzepatide reduces body weight and body fat more effectively than the medication alone. It also explores whether this combination improves other health factors, such as blood sugar, cholesterol, fitness, and quality of life. Participants will either take the medication and exercise or just take the medication. Suitable candidates include those living with overweight or obesity and additional health concerns like high cholesterol or high blood pressure. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to groundbreaking research.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are taking medication for type 1 or 2 diabetes, you would not be eligible to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that tirzepatide, the medication under study, has been tested in people before. Some participants experienced side effects such as nausea, diarrhea, and vomiting. However, only a small number stopped taking the medication due to these issues. Specifically, depending on the dosage, 2.6% to 7.1% of participants discontinued treatment because of side effects.
Although more is being learned about tirzepatide, it has been approved for treating other conditions like type 2 diabetes, indicating it has passed certain safety checks. However, like any medication, it can cause side effects. It's always important to discuss any concerns with a healthcare provider.12345Why do researchers think this study treatment might be promising?
Tirzepatide is unique because it combines the benefits of a hormone that targets both GLP-1 and GIP receptors, which are involved in regulating blood sugar and appetite. Unlike the standard treatments for obesity, such as lifestyle changes and medications that primarily focus on just the GLP-1 receptor, tirzepatide's dual action helps enhance weight loss by addressing multiple pathways. Researchers are excited about tirzepatide because it could lead to greater and more effective weight loss, offering a promising new option for those struggling with obesity.
What evidence suggests that this trial's treatments could be effective for obesity?
Research has shown that tirzepatide aids weight loss in individuals with obesity. In one study, participants lost significant weight after taking tirzepatide weekly for 72 weeks. Another study found that those who continued using tirzepatide maintained their weight loss, while those who stopped regained weight. In everyday use, individuals lost about 12.9% of their weight after six months of treatment. This trial will compare two approaches: one group will receive tirzepatide with an exercise regimen, while another group will receive standard care with tirzepatide alone. These findings suggest that tirzepatide can help maintain weight loss over time.16789
Who Is on the Research Team?
Damon L Swift, Ph.D
Principal Investigator
University of Virginia
Are You a Good Fit for This Trial?
Adults aged 30-65 with obesity or overweight and additional heart-related risk factors can join this trial. They must be healthy enough for weight loss medication, willing to consent, and have their doctor's approval.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive tirzepatide monthly and engage in exercise (for the exercise group) for 16 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Exercise
- Tirzepatide
Trial Overview
The study tests if exercise combined with the weight loss drug Tirzepatide is more effective than the drug alone in reducing body weight/fat and improving blood sugar, cholesterol levels, fitness, and quality of life.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will perform aerobic and resistance exercise while taking monthly tirzepatide for 16 weeks
Participants will take monthly Tirzepatide under the care of their primary care provider for 16 weeks
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Virginia
Lead Sponsor
Citations
Tirzepatide Once Weekly for the Treatment of Obesity
In this 72-week trial in participants with obesity, 5 mg, 10 mg, or 15 mg of tirzepatide once weekly provided substantial and sustained reductions in body ...
Real-world use and effectiveness of tirzepatide among ...
While tirzepatide dose escalation was slower than in clinical trials, individuals achieved weight reduction at 6 months, consistent with ...
Continued Treatment With Tirzepatide for Maintenance of ...
In participants with obesity or overweight, withdrawing tirzepatide led to substantial regain of lost weight, whereas continued treatment maintained and ...
Real-world use and effectiveness of tirzepatide among ...
In the current study, individuals who persisted on tirzepatide for 6 months experienced mean weight reduction of 12.9 % at 6 months post-index, although most ...
Real‐world use and effectiveness of tirzepatide among ...
While tirzepatide dose escalation was slower than in clinical trials, individuals achieved weight reduction at 6 months, consistent with ...
Real-World Safety Concerns of Tirzepatide
Despite its efficacy, real-world safety data remain limited. This study analyzed post-marketing adverse events (AEs) associated with tirzepatide ...
FDA's Concerns with Unapproved GLP-1 Drugs Used for ...
FDA is aware of fraudulent compounded semaglutide and tirzepatide marketed in the U.S. that contain false information on the product label. In ...
Tirzepatide safety in type 2 diabetes: a disproportionality ...
This study evaluated adverse events reported with tirzepatide, a dual GIP/GLP-1 receptor agonist approved for type 2 diabetes and obesity, using real-world data ...
Tirzepatide and cardiometabolic parameters in obesity ...
7 SUMMARY OF SAFETY DATA THUS FAR ... Tirzepatide use is associated with gastrointestinal symptoms, most commonly nausea, diarrhoea, vomiting, ...
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